BEUDAMED
    FDA Recall Terminated

    Alsius Cool Line Catheter, Model CL-2295AE

    Recall: Z-0503-2007 · Initiated January 1, 2007

    Recall

    Recall Number
    Z-0503-2007
    Event Number
    37192
    Firm
    Alsius Corporation
    FEI Number
    3002922896
    Product Code
    NCX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 1, 2007
    Posted
    February 15, 2007
    Terminated
    June 22, 2007
    Address
    15770 Laguna Canyon Rd, Ste 150, Irvine, CA, 92618-3111

    Description

    Alsius Cool Line Catheter, Model CL-2295AE

    Reason

    Testing by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a significant reduction in their heat exchange capacity.

    Action

    Customer letters were sent starting January 1, 2006 via FEDEX and DHL. Verification of receipt of the notification letter to level A will be undertaken by using tracked delivery requiring signature upon receipt . The Customer letters will notify consignees of the nature of the problem and provide instructions to return the product.

    Distribution

    Worldwide including USA, Austria, Canada, France, Greece, Japan, Norway, Spain & Switzerland

    Quantity

    125